EUS Guided Liver Biopsy - Will it Give Better Yield, More Tissue With Less Complication?

January 3, 2022 updated by: Dr Mithun Sharma, Asian Institute of Gastroenterology, India

EUS Guided Liver Biopsy Proposal Titled : EUS Guided Liver Biopsy - Will it Give Better Yield , More Tissue With Less Complication ?

Liver biopsy would be done by Endoscopic Ultrasound using Acquire needle.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, we aim to evaluate the tissue adequacy of EUS guided liver biopsy for parenchymal liver disease and to evaluate if diagnostic yield of left lobe is non-inferior to right lobe biopsies and to assess if combination biopsies have better yield than single lobe biopsies. Safety of the procedure and technical success would be noted.

The data would be analysed using SPSS software and needful variables and tests would be used as per statistical requirement.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500089
        • Asian Institute of Gastroenterology Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of any undiagnosed hepatic disease (after extensive investigation - serological as well as imaging) requiring a liver biopsy
  • Patients of NAFLD who need liver biopsy
  • Alcoholic hepatitis patients needing biopsy
  • Any patient with unexplained transaminesemia > 1.5 times ULN needing a liver biopsy as advised by Hepatologist

Exclusion Criteria:

  • Any liver Space occupying lesion suspicious of malignancy
  • Platelet count <80,000
  • INR > 1.5
  • Pregnancy
  • Severe cardiovascular and pulmonary diseases
  • Recent use of anti-platelet agents within 5 days of the procedure
  • Unwilling to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopic USG guided Liver biopsy
Olympus linear echo endoscope (GF -UCT 180, Olympus Ltde, Tkyo, Japan) will be used. 19 Gz EUS Acquire needle Boston ©Scientific Corp will be used for liver tissue acquisition.
Device: Endoscopic USG guided Liver biopsy
Diagnostic yield with EUS guided liver biopsy - Left lobe Bx vs combined right and left lobe or vs right lobe would be assessed.
Active Comparator: Percutaneous Liver biopsy
All liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield .
Device: Percutaneous Liver Biopsy
All liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield with EUS guided liver biopsy .
Time Frame: 3 days
The diagnostic yield of a right lobe biopsy and left lobe biopsy would be compared to see if right lobe biopsy gives any additional information for diagnosis when compared to left lobe .
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of procedure
Time Frame: 3 days
Sedation related adverse effect will be monitored as per the institute protocol . Any type of bleed during procedure or needing additional intervention would be recorded as a major adverse effect .
3 days
Duration of procedure
Time Frame: 30 minutes
Time between start and end of the procedure would be noted .
30 minutes
Size of tissue acquired
Time Frame: 3 days
The length of the biopsy tissue would be ascertained immediately by onsite pathologist and would be assessed as per the AASLD and Royal College of Pathology definition .
3 days
Number of portal tracts
Time Frame: 3 days
The adequacy of the sample would be assessed as per the AASLD and Royal College of Pathology definition (CPTs 11) .
3 days
Post procedural complications
Time Frame: 3 days
Any procedure related complications such as pain (>6 on VAS) and bleeding would be noted .
3 days
NAS score in fatty liver patients
Time Frame: 3 days
Difference in NAS score between right lobe and right vs left lobe in fatty liver patients
3 days
Patient recovery time
Time Frame: 3 days
Patient recovery time when compared to per cutaneous liver biopsy procedure .
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2019

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

January 18, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECR/346/Inst/AP/2013/RR-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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